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Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy

Sponsor
Ospedale Policlinico San Martino (Other)
Overall Status
Recruiting
CT.gov ID
NCT04774146
Collaborator
(none)
20
Enrollment
1
Location
5.1
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. Purpose of the study is to compare the amount of silicone oil emulsification droplets within the lavage fluid in case of air exchange and simple lavage to compare which technique removed the highest percentage of emulsion. This is achieved by comparing consecutive samples of lavage fluid

Condition or Disease Intervention/Treatment Phase
  • Procedure: pars plana vitrectomy

Detailed Description

silicone oil tamponade removal after previous injection of complicated retinal detachment can be achieved with active suction followed by triple air-fluid exchange or prolonged lavage of the vitreous chamber to remove emulsification. Purpose of the study is to compare the amount of silicone oil emulsification droplets within the lavage fluid in case of air exchange and simple lavage to compare which technique removed the highest percentage of emulsion. This is achieved by comparing consecutive samples of lavage fluid.

Therefore consecutive patients scheduled to SiO removal with triple air exchange or vitreous chamber lavage are enrolled and 3 samples of intraocular fluid aspirated during the fluid exchange procedure sent to the lab for SiO emulsion count and quantification.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Quantification of Silicone Oil Emulsification After Pars Plana Vitrectomy
Actual Study Start Date :
Jun 1, 2021
Actual Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Nov 3, 2021

Arms and Interventions

Arm Intervention/Treatment
triple air fluid exchange

those undergoing triple air fluid exchange

Procedure: pars plana vitrectomy
silicone oil active aspiration and isovolumetric BSS replacement followed by irrigation and /o gas fluid exchange
irrigation

those undergoing vitreous chamber irrigation with comparable volume of BSS

Procedure: pars plana vitrectomy
silicone oil active aspiration and isovolumetric BSS replacement followed by irrigation and /o gas fluid exchange

Outcome Measures

Primary Outcome Measures

  1. number of silicone oil emulsification droplets per volume unit [6 months after primary surgery]

    number of silicone oil emulsification droplets per volume unit. Fluid taken from the vitreous chamber during surgery is subsequently analyzed. Therefore time frame is just one: after taking all samples they are analyzed to count oil droplets per volume unit

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • previous silicone oil tamponade after pars plana vitrectomy

  • age >18 years

  • Attached retina

Exclusion Criteria:

  • unwilling or unable to participate,

  • previous multiple eye surgery

  • History of Trauma

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Policlinico San Martino Genova RM Italy 16100

Sponsors and Collaborators

  • Ospedale Policlinico San Martino

Investigators

  • Study Director: Tommaso Rossi, IRCCS Policlinico San MArtino

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ospedale Policlinico San Martino
ClinicalTrials.gov Identifier:
NCT04774146
Other Study ID Numbers:
  • 1/2000
First Posted:
Mar 1, 2021
Last Update Posted:
Oct 27, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Retinal Detachment

Study Results

No Results Posted as of Oct 27, 2021